Prevalence, pathogenesis, and causes of chronic cough.
Kian Fan Chung, Ian D Pavord
https://pubmed.ncbi.nlm.nih.gov/18424325Actively Recruiting
Early Phase 1
Age: 18Years - 65Years
All Genders
ID05813223
Effect of Acute and Prolonged Gefapixant Treatment on Brain Activity Related to Cough in Adults With Chronic Cough
Led by Stuart Mazzone · Updated on 2024-05-09
31
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
Sponsors
S
Stuart Mazzone
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Chronic cough affects about one in ten people worldwide, causing frequent coughing and an ongoing urge to cough that can last for years without relief. This research aims to study how the drug Gefapixant affects brain activity related to coughing in people with chronic cough, especially looking at differences between short-term and long-term treatment effects. Gefapixant has recently passed phase III trials and is being further studied for its impact on brain pathways controlling cough and urge-to-cough sensations. Participants will take 45 mg of Gefapixant twice daily for 12 weeks. Brain scans using magnetic resonance imaging will be done before treatment, after 3 days, and after 12 weeks of taking the drug. After stopping Gefapixant for one week, another scan will assess if brain changes persist. Participants will then have access to the drug for an additional 9 months with follow-up assessments to see if longer-term use leads to further changes in cough-related nerve pathways. Throughout the study, participants will complete questionnaires and keep a daily diary about their cough. Researchers will measure brain activity related to coughing, sensitivity to cough-inducing substances, and various cough severity and quality-of-life scores at multiple time points. These assessments will continue daily during treatment, after stopping the drug, and during the extended follow-up period, which lasts up to 12 months from the start of the study.
CONDITIONS
Brief Title
Effect of Gefapixant on Cough-related Brain Activity in Patients With Chronic Cough
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Written informed consent to participate in the study
- Age between 18 and 65 years, male or female
- Non-smoker for at least 5 years
- No history of neurological disease or recent acute respiratory infections over the past 8 weeks
- Diagnosis of refractory or unexplained chronic cough lasting at least 1 year
- Self-reported cough severity of 40 mm or more on a 10-point scale at screening
You will not qualify if you...
- Current smokers or recreational drug users
- Women who are pregnant
- Contraindications to MRI scanning such as metal implants or claustrophobia
- Children or young people under 18 years
- Intellectual or mental impairment
- Highly dependent on medical care
- Existing dependent or unequal relationships with research team members
- Known allergy to chili
- Non-English speakers as English proficiency is required for research tasks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants take Gefapixant tablets (45mg twice daily) for 12 weeks while undergoing brain scans, cough challenge tests, and completing questionnaires and cough diaries to assess the effects on cough and brain activity.
Brain scans before, 3 days after, and 12 weeks after starting treatment; questionnaires and cough diaries collected regularly during treatment
Follow-up
Duration - 1 week
Participants stop Gefapixant for 1 week and undergo brain scans, cough tests, and questionnaires to assess whether treatment effects are sustained.
1 visit for brain scan and assessments 1 week after stopping treatment
Long-term Monitoring
Duration - 9 months
Participants have access to Gefapixant for up to 9 additional months with periodic assessments to evaluate longer term effects on cough and brain activity.
2 assessment visits during the 9 months; daily cough diaries maintained
Trial Site Locations
Total: 1 location
1
The University of Melbourne
Parkville, Victoria, Australia, 3010
Actively Recruiting
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Research Team
S
Stuart B Mazzone, PhD
T
Tara G Bautista, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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Dennis Thomas, Peter G Gibson
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Lorcan P McGarvey, Surinder S Birring, Alyn H Morice...
https://pubmed.ncbi.nlm.nih.gov/35248186Gefapixant, a P2X3 receptor antagonist, for the treatment of refractory or unexplained chronic cough: a randomised, double-blind, controlled, parallel-group, phase 2b trial.
Jaclyn A Smith, Michael M Kitt, Alyn H Morice...
https://pubmed.ncbi.nlm.nih.gov/32109425A worldwide survey of chronic cough: a manifestation of enhanced somatosensory response.
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https://pubmed.ncbi.nlm.nih.gov/25186267The effect of gefapixant, a P2X3 antagonist, on cough reflex sensitivity: a randomised placebo-controlled study.
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https://pubmed.ncbi.nlm.nih.gov/31023843Safety of capsaicin cough challenge testing.
Peter V Dicpinigaitis, Rakesh V Alva
https://pubmed.ncbi.nlm.nih.gov/16002935